Machine learning (ML) revolutionizes the medical field by enabling faster disease detection, more accurate diagnoses, and personalized treatments. These advancements rely heavily on the vast amounts…
Rook Quality Systems offers comprehensive clinical evaluation services to medical device clients, assisting clients with navigating the development and regulatory approval process. Our strategy emphasizes the…
As we step into the new year, we asked our team members to share their insights by forecasting five daring trends in medical device quality for…
This post is part of a two-part series. You can read Part 1 here In the ever-evolving landscape of medical technology, the regulation of Laboratory Developed…
When medical devices are user-friendly there is a higher probability for users to continue using the device for clinical or personal purposes and highly recommend the…
What is the Medical Device Development Tools (MDDT) program? The FDA initiated the Medical Device Development Tools (MDDT) program to facilitate device development and the timely…